Compliance Specialist/ Technical Writer

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.

This company discovers, develops and produces new innovative human therapeutics that improve the life expectancy of humanity.

ROLE DESCRIPTION

As the compliance specialist/ technical writer you will be responsible for the reporting of CAPAs within the supply chain department.

RESPONSIBILITIES

- All activities within the quality system associated with the Supply Chain nonconformance investigations, CAPA records
- First point of contact for identification and alerting of potential deviations to department standard processes
- Ensure timely completion of Supply Chain non-conformances, investigations, CAPAs through the nonconformance procedures
- Support the customer service and transportation teams with a number of writing tasks including completion of Class 1 & 2 NC investigation reports
- Monitor and manage the NC-CAPA team workload for the department, including escalation when timelines for record completion are at risk
- Contribute, oversee, run and participate in root cause analysis, implementing improvements and corrective actions
- Perform trend analysis of non-conformances relating to Supply Chain
- Ensure investigations constantly reflect current requirements and expectations
- Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings
- Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals
- Ensure flow of communication to stakeholders
- Develop strong working relationships with International Quality, departmental subject matter experts and managers
- Facilitate (chair) periodic quality management review meetings as well as cross-departmental (Regional Supply Chain/Security/International Quality) meetings addressing compliance/quality topics
- Author, own and manage Standard Operating Procedures for Europe Supply Chain organization in the documentation system
- Manage assigned change control tasks
- Identify improvement areas and partner to develop business cases

REQUIREMENTS

- Bachelor degree preferably in pharmaceutical studies
- Experience in (preferably) the pharmaceutical industry
- Strong cGMP and GDP knowledge
- Strong communication and presentation skills (verbal & written)
- Proactive, assertive, well organized person with an eye for detail possessing strong analytical and social skills
- Strong knowledge of ERP system/GMP compliance
- Experience with electronic Quality Management systems (e.g. TrackWise)
- Scientific & regulatory writing skills to produce reports in line with compliance requirements
- Exposure to root cause analysis and other investigation tools (5-whys etc.)
- Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information
- Excellent English verbal and written communication skills including technical writing, presentation and facilitation skills
- Experience with non-conformances, investigations, CAPAs
- Experience of authoring documents in a controlled document system
- Ability to evaluate complex compliance issues
- Awareness of Change Control philosophy in the cGMP environment
- Understanding of the requirements of EU Good Distribution Practices
- Strong data analysis skills
- Operational excellence mindset

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Pascha Groot.